Medication adherence issues account for a significant amount of unnecessary expenditures and may result in suboptimal healthcare outcomes and/or problems for patients.
Adherence to medication intake (the administering of the correct dosage at the correct date and time) has been a significant challenge in the healthcare field. While there may be a number of products designed to promote adherence to medication, these products have not been very effective. For example, a patient may be provided with several pharmaceutical products for consumption at various times of the day, with the timing of the intake of the products, as well as the dosages being important (e.g., based on a dosing regimen) from a pharmacokinetic perspective (e.g., maintaining a therapeutic dosage level in the bloodstream).
Deviating from the particular dosage regimen may have adverse effects on the health of a patient (e.g., straying outside a therapeutic range, straying into a range having toxic side effects), and may also result in increased costs and/or the proliferation of medicines that should have otherwise been consumed by patients (e.g., proliferation of hydrocodone).
The failure of patients to adhere to their medication regime properly can also be detrimental to clinical research. Participants in phase 3 and 4 drug trials are simply being trust to take their medication properly and report their results at the end of the trial. Without any existing measures in place to document how the patients in these trials are taking their medication, non-compliant patients may be included in the data set of these trials. This inaccurately reports the effects of the medication, and can result in the medication not achieving regulatory approval.
Some devices and techniques require manual administration and loading by the patient, a care giver, professional support worker or a pharmacist. Unsurprisingly, manual administration has led to devices that are prone to error and adherence failure, with an inability to conduct practical monitoring of patient adherence. Further, the devices may also be loaded incorrectly, causing potential harm to a patient (e.g., a practitioner unintentionally loads a device with the wrong dosage or type of medication).
At the present time, compliance data, if it is recorded at all, is being documented manually in a very unscientific way. If a patient has pills remaining at the end of a trial, they are averaged out to get a compliance percentage. This may be documented using Electronic Data Capture Applications such as InForm by Oracle, MediData Rave by MediData Solutions, and iDataFax by Clinical DataFax Systems. Some trials still use paper and fax-based methods. In both cases, these may require manual entry, and the data is being recorded after-the-fact—often long after the medication has been taken, which may lead to inaccuracies in the data, and not being able to guarantee proper drug compliance.
A significant portion of the population is being treated for multiple chronic diseases. In Canada, approximately one third of the population (12 million) is on at least one chronic medication. Of these 12 million Canadians, 3 million are over the age of 65 and are beginning to face the challenges of managing multiple medications. Non-adherence is a problem across all ages, for example, for children with risks from asthma, cancer, organ transplants, etc.